Identity
- Trade Name
- HemosIL Liquid Anti-Xa FDA UDI
- Generic Name
- Coagulation factor Xa inhibitor IVD, kit, clotting FDA UDI
- Device Name
- HemosIL Liquid Anti-Xa 1. Factor Xa Reagent (0020302612) 5 x 2.5 mL 2. Chromogenic substrate (0020302622) 5 x 3 mL FDA UDI
- Model / Reference
- 0020302602 FDA UDI
- Description
- HemosIL Liquid Anti-Xa 1. Factor Xa Reagent (0020302612) 5 x 2.5 mL 2. Chromogenic substrate (0020302622) 5 x 3 mL FDA UDI
Identifiers
- Catalog Number
- 00020302602 FDA UDI
- Primary DI / UDI-DI
- 00195226000016 FDA UDI
- FDA Product Code
- QLU FDA UDI
- GMDN Term
- Coagulation factor Xa inhibitor IVD, kit, clotting FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7295 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Coagulation factor Xa inhibitor IVD, kit, clotting
HemosIL Liquid Anti-Xa by Instrumentation Laboratory Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coagulation factor Xa inhibitor IVD, kit, clotting.
- HemosIL Liquid Anti-Xa — INSTRUMENTATION LABORATORY COMPANY · Class II
Cleared under the same submission
DEN190032 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Instrumentation Laboratory Company
Sources (1)
- FDA UDI a23cefc2-5ccd-478e-b5fc-4775f94a9c78 37 fields · synced Jun 8, 2026